Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Sponsor
Guangzhou Medical University
Study ID
NCT01578668
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib — DRUG
    150 mg given orally (po), daily (QD), starting on the 4th day of each cycle, ending on the 21th day before the next cycle, and until disease PD
  • pemetrexed — DRUG
    500 mg/m² intravenous (iv) over 15 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity or no more than 6 cycles
  • cisplatin — DRUG
    cisplatin 20mg/m² iv on the 1st-3rd day (if PS\<2) or 30 mg iv on the 1st-2nd day (if PS=2 or 3)of each cycle until PD or unacceptable toxicity or no more than 6 cycles
  • erlotinib — DRUG
    150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Study Details

The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Key Dates

First listed
Apr 17, 2012
Start date
Jan 31, 2012
Status verified
Jan 2015
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015

Study Design

Enrollment
69 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib, pemetrexed, cisplatin
  • Experimental: erlotinib

Primary Outcome Measure

The objective response rate of brain metastases [ Time Frame: Patients will be followed for an expected average of 6 weeks ]

Related Studies